Nonmalignant NeoplasmPhase 3NCT00632138
Pelvic Floor Muscle Training and Biofeedback or Standard Therapy in Men Who Have Undergone Radical Prostatectomy or Transurethral Resection of the Prostate
A Phase 3 study testing exercise intervention, questionnaire administration and biofeedback in people with Nonmalignant Neoplasm and Prostate Cancer, run by Aberdeen Royal Infirmary at 37 sites in United Kingdom.
Trial summary
RATIONALE: Personalized training by a health professional may improve urinary incontinence. It is not yet known whether pelvic floor muscle training and biofeedback are more effective than standard therapy in improving urinary continence after radical prostatectomy or transurethral resection of the prostate. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Nonmalignant Neoplasm, Prostate Cancer, Psychosocial Effects of Cancer and Its Treatment
- What is being tested?
- exercise intervention, questionnaire administration and biofeedback
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 800 participants
- Where
- 37 sitesUnited Kingdom
- Study dates
- Jan 2005to Jul 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Men who have undergone a radical prostatectomy for prostate cancer or men who have undergone a transurethral resection of the prostate for benign prostatic hypertrophy
- Urinary incontinence at six weeks after prostate surgery
- Incontinence is defined as a response on the screening questionnaire indicating a loss of urine including how often and how much
PATIENT CHARACTERISTICS:
- Able to comply with intervention
- Able to complete study questionnaires
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No referral for formal therapy (teaching of pelvic floor muscle training) due to prostate surgery
- No concurrent or planned radiotherapy during the first 3 months after surgery
- No palliative endoscopic resection of prostate due to outflow obstruction for advanced prostate cancer
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
United Kingdom37 sites
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN
Tameside General Hospital
Ashton-under-Lyne, England, OL6 9RW
Ayr Hospital
Ayr, Scotland, KA6 6DX
Southmead Hospital
Bristol, England, BS10 5NB
Bristol Royal Infirmary
Bristol, England, BS2 8HW
University Hospital of Wales
Cardiff, Wales, CF14 4XW
Mid Cheshire Hospitals Trust- Leighton Hopsital
Crewe, England, CW1 4QJ
Ninewells Hospital
Dundee, Scotland, DD1 9SY
Queen Margaret Hospital - Dunfermline
Dunfermline, Scotland, KY12 0SU
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, Scotland, EH4 2XU
Falkirk and District Royal Infirmary
Falkirk, Scotland, FK1 5QE
Royal Bolton Hospital
Farnworth, England, BL4 0JR
Southern General Hospital
Glasgow, Scotland, G51 4TF
Inverclyde Royal Hospital
Greenock, Scotland, PA16 0XN
King George Hospital
Ilford, Essex, England, IG3 8YB
Raigmore Hospital
Inverness, Scotland, 1V2 3UJ
Ipswich Hospital
Ipswich, England, IP4 5PD
Airedale General Hospital
Keighley, England, BD20 6TD
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, LS9 7TF
St. Mary's Hospital
London, England, W2 1NY
Macclesfield District General Hospital
Macclesfield, England, SK10 3BL
James Cook University Hospital
Middlesbrough, England, TS4 3BW
Freeman Hospital
Newcastle upon Tyne, England, NE7 7DN
Norfolk and Norwich University Hospital
Norwich, England, NR4 7UY
Nottingham City Hospital
Nottingham, England, NG5 1PB
Berkshire Cancer Centre at Royal Berkshire Hospital
Reading, England, RG1 5AN
Queens Hospital
Romford, England, RM3 0BE
Hope Hospital
Salford, England, M6 8HD
Royal Hallamshire Hospital
Sheffield, England, S1O 2JF
Lister Hospital
Stevenage, England, SG1 4AB
Stepping Hill Hospital
Stockport, England, SK2 7JE
Taunton and Somerset Hospital
Taunton, England, TA1 5DA
Hillingdon Hospital
Uxbridge, England, UB8 3NN
Pinderfields General Hospital
Wakefield, Scotland, WF1 4DG
Morriston Hospital NHS Trust
West Glamorgen, Scotland, SA6 6NL
New Cross Hospital
Wolverhampton, England, WV10 0QP
Yeovil District Hospital
Yeovil, England, BA21 4AT
About this study
Official title: MAPS (Men After Prostate Surgery) : Conservative Treatment for Men With Urinary Incontinence After Prostate Surgery; Multicentre Randomised Controlled Trial of Pelvic Floor Muscle Training and Biofeedback [MAPS]
RATIONALE: Personalized training by a health professional may improve urinary incontinence. It is not yet known whether pelvic floor muscle training and biofeedback are more effective than standard therapy in improving urinary continence after radical prostatectomy or transurethral resection of the prostate.
PURPOSE: This randomized phase III trial is studying pelvic floor muscle training and biofeedback to see how well it works compared with standard therapy in men who have undergone radical prostatectomy or transurethral resection.
Read the detailed description
OBJECTIVES:
- To establish whether conservative physical treatment delivered personally by a trained health professional results in better urinary and other outcomes compared with standard management in men who are incontinence after prostate surgery.
OUTLINE: This is a multicenter study. Patients are stratified according to type of operation (radical prostatectomy vs transurethral resection of prostate). Patients are randomized to 1 of 2 treatment arms.
- Arm I (intervention group): At 6 weeks after surgery, patients undergo an assessment of their symptoms by a physiotherapist or continence nurse. All patients are taught pelvic floor muscle training and men with urgency or urge incontinence are also taught bladder training. Pelvic floor training consists of 3 maximum pelvic floor contractions in 3 positions (standing, sitting, and lying down) twice a day, lifting of the pelvic floor while walking, tightening of the pelvic muscles before activities, and tightening of the pelvic muscles after urinating to squeeze out any last drops. The strength of the pelvic floor contractions is monitored by biofeedback involving digital anal assessment and relaying the information back to men in order that they know when they are performing contractions correctly and to inform them when they are increasing the strength or duration of their contractions. Therapists may use machine-mediated biofeedback with an anal biofeedback probe at their discretion in addition to digital anal assessment. Bladder training consists of gradually delaying urination by pelvic floor muscle contraction and distracting activities to teach the bladder to hold increasing volumes of urine. Patients also receive a customized Pelvic Floor Exercise Booklet describing pelvic floor muscle training in addition to a customized Lifestyle Advice Booklet giving general lifestyle advice. Patients have reinforcement sessions at approximately 2, 6, and 12 weeks after the first appointment.
- Arm II (control group): Patients receive a customized Lifestyle Advice Booklet containing supportive lifestyle advice only (without reference to pelvic floor muscle training) by mail following randomization. Patients do not receive formal assessment or treatment but will be able to access usual care and routine NHS services if they feel they need help, including written advice if this is part of routine hospital care.
All patients keep a urinary diary at 3, 6, 9, and 12 months that includes frequency of urination (day and night), daily episodes of incontinence and quantity of loss, daily use of pads, and the need to change clothing or bedding. A Health Care Utilization Questionnaire will be obtained at 3 and 9 months. Additional questionnaires are obtained at baseline and 6 and 12 months.
The use of NHS services, pads, and practice of pelvic floor muscle training is documented in both groups using information from questionnaires and Urinary Diaries.
Six months after the last patient has been recruited, a check for Scottish men only is performed to compare self-reported operations, diagnoses, and hospital admissions with centrally collected data to validate a proportion of the data.
After completion of study treatment, patients are followed at 6 and 12 months.
- Conditions
- Nonmalignant Neoplasm, Prostate Cancer, Psychosocial Effects of Cancer and Its Treatment, Sexual Dysfunction, Urinary Incontinence
- Being tested
- exercise intervention, questionnaire administration, biofeedback, management of therapy complications, psychosocial assessment and care
- Keywords
- sexual dysfunction, psychosocial effects of cancer and its treatment, prostate cancer, benign prostatic hyperplasia, urinary incontinence
- Medical subject headings
- Neoplasms, Prostatic Neoplasms, Sexual Dysfunction, Physiological, Urinary Incontinence, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise interventionBehavioural
questionnaire administrationOther
biofeedbackProcedure or surgery
management of therapy complicationsProcedure or surgery
psychosocial assessment and careProcedure or surgery
quality-of-life assessmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective report of urinary continence at 12 months
Incremental cost per quality-adjusted year
Secondary outcomes (23)
Subjective report of continence or improvement of urinary incontinence at 3, 6, and 9 months after randomization and improvement at 12 months
Objective report of the number of incontinent episodes in the previous week from the urinary diary
Duration of incontinence based on time of resolution relative to time of operation and randomization
Use of absorbent pads, penile collecting sheath, bladder catheter, or bed/chair pads
Number and type of incontinence products used
Co-existence, cure or development of urgency, or urge incontinence
Urinary frequency
Nocturia
Fecal incontinence (passive or urge)
Other bowel dysfunction (i.e., urgency, constipation, or other bowel diseases)
Sexual function at 12 months including information about erection, ejaculation, retrograde ejaculation, pain, change in sex life, and reason for change
Incontinence-specific quality of life outcome measure using the 10-point scale and ICI questionnaire
General health measures
Need for alternative management for incontinence (e.g., surgery or drugs)
Use of GP, nurse, consultant urologist, or physiotherapist
Visits to GP
Visits to practice nurse
Use of pelvic floor muscle training
Lifestyle changes (i.e., weight, constipation, lifting, coughing, or exercise)
Patient costs (e.g., self care [e.g., pads or laundry], travel to health services, or sick leave)
Cost of conservative trial treatment
Cost of alternative or additional NHS treatments (e.g., pads, catheters, drugs [e.g., adrenergic agonists, anticholinergics, or oral medication for erectile dysfunction], hospital admissions, or further surgery)
Other measures of cost-effectiveness (e.g., incremental cost per additional man continent at 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2008 (estimated)
- Study startJan 2005
- Primary completionDec 2008
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nonmalignant NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aberdeen Royal Infirmary
- Sponsor type
- University, hospital or other
- Investigators
- Cathryn Glazener, MD, Study chair, Aberdeen Royal Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00632138
- Sponsor's protocol ID
- ABROIN-MAPS
- Other IDs
- CDR0000586420, ISRCTN87696430
- Status last verified
- Dec 2008
- First submitted
- 7 Mar 2008
- Last updated
- 7 Aug 2013
- Results posted
- No
Publications
Johnson EE, Mamoulakis C, Stoniute A, Omar MI, Sinha S. Conservative interventions for managing urinary incontinence after prostate surgery. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD014799. doi: 10.1002/14651858.CD014799.pub2.
PubMed 37070660
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MAPS (Men After Prostate Surgery) : Conservative Treatment for Men With Urinary Incontinence After Prostate Surgery; Multicentre Randomised Controlled Trial of Pelvic Floor Muscle Training and Biofeedback [MAPS]
- ClinicalTrials.gov ID
- NCT00632138
- Acronym / sponsor ID
- ABROIN-MAPS
- Conditions
- Nonmalignant Neoplasm, Prostate Cancer, Psychosocial Effects of Cancer and Its Treatment, Sexual Dysfunction, Urinary Incontinence
- Keywords
- sexual dysfunction, psychosocial effects of cancer and its treatment, prostate cancer, benign prostatic hyperplasia, urinary incontinence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Aberdeen Royal InfirmaryUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 10 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Personalized training by a health professional may improve urinary incontinence. It is not yet known whether pelvic floor muscle training and biofeedback are more effective than standard therapy in improving urinary continence after radical prostatectomy or transurethral resection of the prostate.
PURPOSE: This randomized phase III trial is studying pelvic floor muscle training and biofeedback to see how well it works compared with standard therapy in men who have undergone radical prostatectomy or transurethral resection.
Detailed description
OBJECTIVES:
- To establish whether conservative physical treatment delivered personally by a trained health professional results in better urinary and other outcomes compared with standard management in men who are incontinence after prostate surgery.
OUTLINE: This is a multicenter study. Patients are stratified according to type of operation (radical prostatectomy vs transurethral resection of prostate). Patients are randomized to 1 of 2 treatment arms.
- Arm I (intervention group): At 6 weeks after surgery, patients undergo an assessment of their symptoms by a physiotherapist or continence nurse. All patients are taught pelvic floor muscle training and men with urgency or urge incontinence are also taught bladder training. Pelvic floor training consists of 3 maximum pelvic floor contractions in 3 positions (standing, sitting, and lying down) twice a day, lifting of the pelvic floor while walking, tightening of the pelvic muscles before activities, and tightening of the pelvic muscles after urinating to squeeze out any last drops. The strength of the pelvic floor contractions is monitored by biofeedback involving digital anal assessment and relaying the information back to men in order that they know when they are performing contractions correctly and to inform them when they are increasing the strength or duration of their contractions. Therapists may use machine-mediated biofeedback with an anal biofeedback probe at their discretion in addition to digital anal assessment. Bladder training consists of gradually delaying urination by pelvic floor muscle contraction and distracting activities to teach the bladder to hold increasing volumes of urine. Patients also receive a customized Pelvic Floor Exercise Booklet describing pelvic floor muscle training in addition to a customized Lifestyle Advice Booklet giving general lifestyle advice. Patients have reinforcement sessions at approximately 2, 6, and 12 weeks after the first appointment.
- Arm II (control group): Patients receive a customized Lifestyle Advice Booklet containing supportive lifestyle advice only (without reference to pelvic floor muscle training) by mail following randomization. Patients do not receive formal assessment or treatment but will be able to access usual care and routine NHS services if they feel they need help, including written advice if this is part of routine hospital care.
All patients keep a urinary diary at 3, 6, 9, and 12 months that includes frequency of urination (day and night), daily episodes of incontinence and quantity of loss, daily use of pads, and the need to change clothing or bedding. A Health Care Utilization Questionnaire will be obtained at 3 and 9 months. Additional questionnaires are obtained at baseline and 6 and 12 months.
The use of NHS services, pads, and practice of pelvic floor muscle training is documented in both groups using information from questionnaires and Urinary Diaries.
Six months after the last patient has been recruited, a check for Scottish men only is performed to compare self-reported operations, diagnoses, and hospital admissions with centrally collected data to validate a proportion of the data.
After completion of study treatment, patients are followed at 6 and 12 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise intervention | Behavioural | – |
| questionnaire administration | Other | – |
| biofeedback | Procedure or surgery | – |
| management of therapy complications | Procedure or surgery | – |
| psychosocial assessment and care | Procedure or surgery | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
Subjective report of urinary continence at 12 months
Incremental cost per quality-adjusted year
23 secondary outcomes
Subjective report of continence or improvement of urinary incontinence at 3, 6, and 9 months after randomization and improvement at 12 months
Objective report of the number of incontinent episodes in the previous week from the urinary diary
Duration of incontinence based on time of resolution relative to time of operation and randomization
Use of absorbent pads, penile collecting sheath, bladder catheter, or bed/chair pads
Number and type of incontinence products used
Co-existence, cure or development of urgency, or urge incontinence
Urinary frequency
Nocturia
Fecal incontinence (passive or urge)
Other bowel dysfunction (i.e., urgency, constipation, or other bowel diseases)
Sexual function at 12 months including information about erection, ejaculation, retrograde ejaculation, pain, change in sex life, and reason for change
Incontinence-specific quality of life outcome measure using the 10-point scale and ICI questionnaire
General health measures
Need for alternative management for incontinence (e.g., surgery or drugs)
Use of GP, nurse, consultant urologist, or physiotherapist
Visits to GP
Visits to practice nurse
Use of pelvic floor muscle training
Lifestyle changes (i.e., weight, constipation, lifting, coughing, or exercise)
Patient costs (e.g., self care [e.g., pads or laundry], travel to health services, or sick leave)
Cost of conservative trial treatment
Cost of alternative or additional NHS treatments (e.g., pads, catheters, drugs [e.g., adrenergic agonists, anticholinergics, or oral medication for erectile dysfunction], hospital admissions, or further surgery)
Other measures of cost-effectiveness (e.g., incremental cost per additional man continent at 12 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
- Derived from this study: PubMed 37070660Johnson EE, Mamoulakis C, Stoniute A, Omar MI, Sinha S. Conservative interventions for managing urinary incontinence after prostate surgery. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD014799. doi: 10.1002/14651858.CD014799.pub2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cathryn Glazener, MD study chair
Aberdeen Royal Infirmary
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing exercise intervention, questionnaire administration and biofeedback in people with Nonmalignant Neoplasm and Prostate Cancer, run by Aberdeen Royal Infirmary at 37 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective report of urinary continence at 12 months. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00632138, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2013.